Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)
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| ClinicalTrials.gov Identifier: NCT02796261 |
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Recruitment Status :
Recruiting
First Posted : June 10, 2016
Last Update Posted : April 18, 2018
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Sponsor:
Orbus Therapeutics, Inc.
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.
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Brief Summary:
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma | Drug: Eflornithine Drug: Lomustine | Phase 3 |
This study will consist of 4 study periods of up to 50 months in total, consisting of:
Screening Period - A maximum screening duration of 4 weeks.
Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period - Up to 24 months.
A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 280 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy |
| Study Start Date : | July 2016 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | August 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
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Experimental: Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
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Drug: Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Other Name: DFMO Drug: Lomustine Lomustine 90 mg/m2 administered orally once every 6 weeks
Other Names:
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Active Comparator: Lomustine
Lomustine dosed every 6 weeks
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Drug: Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Other Names:
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Primary Outcome Measures :
- Overall survival [ Time Frame: 4 years ]
Secondary Outcome Measures :
- Progression-free survival (PFS) [ Time Frame: 4 years ]
- Objective response rate (ORR) [ Time Frame: 4 years ]
Other Outcome Measures:
- Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria [ Time Frame: 4 years ]
- OS rate at 18 months (OS-18) [ Time Frame: 18 months ]
- Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples [ Time Frame: 4 years ]
- Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
- PK - Area under the curve (AUC) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
- Unequivocal evidence of first AA tumor progression or recurrence ≤ 3 months prior to randomization based on MRI criteria for tumor progression using enlarging Gd-contrast enhancement and/or T2 hyperintensity. Patients with non-measurable Gd contrast enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or histopathological confirmation of AA per standard of care procedures is obtained.
- First tumor progression or recurrence following surgical resection or biopsy, if resection is not feasible, EBRT and temozolomide chemotherapy.
- Completion of EBRT ≥ 6 months prior to randomization.
- A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2/FLAIR.
- Karnofsky Performance Status (KPS) score of ≥ 70.
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not eligible for study participation:
- MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
- Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
- Prior systemic therapy for recurrence of AA.
- Presence of extracranial or leptomeningeal disease.
- Prior lomustine use.
- Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
- Pregnant or breastfeeding.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796261
Contacts
| Contact: Marietta Franco, MS | 6504506634 | marietta.franco@orbustherapeutics.com | |
| Contact: Kathleen Villamejor, BS | 6506569424 | kathleen.villamejor@orbustherapeutics.com |
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Sponsors and Collaborators
Orbus Therapeutics, Inc.
Investigators
| Study Director: | Marietta Franco, MS | Orbus Therapeutics, Inc. |
| Responsible Party: | Orbus Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT02796261 History of Changes |
| Other Study ID Numbers: |
OT-15-001 |
| First Posted: | June 10, 2016 Key Record Dates |
| Last Update Posted: | April 18, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Orbus Therapeutics, Inc.:
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Anaplastic Astrocytoma Grade 3 Glioma Glioma Eflornithine Brain Cancer Brain Tumor Neuro-oncology |
Progressive Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma Progressive Glioma Recurrent Glioma Malignant Glioma Progressive Brain Tumor Recurrent Brain Tumor |
Additional relevant MeSH terms:
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Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lomustine Eflornithine |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Ornithine Decarboxylase Inhibitors Enzyme Inhibitors |